Egg Diet to Improve Metabolic Health and Function

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The University of Alabama at Birmingham

Status

Completed

Conditions

Obesity

Treatments

Other: Carbohydrate-based diet (CBD)
Other: Egg-based diet (EBD)

Study type

Interventional

Funder types

Other

Identifiers

NCT02760641
F141016101

Details and patient eligibility

About

The purpose of this study is to determine the effects of change in diet quality (carbohydrate restriction versus fat restriction) on body composition, fat distribution, cardiometabolic risk factors, physical function, and quality of life in aging adults with obesity.

Full description

The purpose of this study is to determine the effects of change in diet quality (carbohydrate restriction versus fat restriction) on body composition, fat distribution, cardiometabolic risk factors, physical function, and quality of life in aging adults with obesity. Data from previous studies support the hypothesis that consumption of lower-CHO, higher-fat food sources rich in high-quality proteins and essential fatty acids, such as whole eggs, has beneficial effects on metabolic health. The study will test the hypothesis that a reduced CHO higher- fat, egg-rich diet induces selective depletion of total and abdominal adiposity, preserves lean mass, and reduces inflammation and oxidative stress. In turn, these favorable changes in body composition, fat distribution, and metabolic health will confer improvements in physical function in obese, aging adults. Results from this study will form an empirical basis for developing an easily implemented, non-pharmacologic treatment (i.e. change diet quality by incorporating more low carbohydrate, whole foods such as eggs) to prevent or reverse sarcopenia and other age-related diseases of metabolic origins.

Enrollment

34 patients

Sex

All

Ages

60 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • between 60-75 years of age,
  • have a BMI ranging from 30-40 kg/m2,
  • sedentary (<2h/wk of intentional exercise, and agree to maintain their level of activity throughout the study).

Exclusion criteria

  • those with uncontrolled diabetes,
  • unwilling to eat the prescribed diets,
  • recent weight change (+/- 10 lbs. in previous year),
  • history of eating disorder,
  • difficulty chewing and swallowing solid food,
  • digestive diseases,
  • cognitive impairment,
  • uncontrolled blood pressure (systolic blood pressure > 159 or diastolic blood pressure >95 mm Hg),
  • history of non-skin cancer in the last 5 years,
  • cardiovascular disease event; severe pulmonary disease; renal failure; major liver dysfunction,
  • current/recent smoker,
  • use of estrogen or testosterone replacement therapy,
  • current use of oral corticosteroids (>5 d/mth),
  • using medications for treatment of psychosis or manic-depressive illness, and
  • dependence on others for food procurement or preparation.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

34 participants in 2 patient groups, including a placebo group

Egg-based diet (EBD)
Experimental group
Description:
This arm will provide ≤25% energy from CHO, 25% energy from protein, and ≥50% energy from fat. EBD participants will be asked to consume ≥2 eggs per day along with other protein sources including meat, fish, pork, and poultry. Carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day.
Treatment:
Other: Egg-based diet (EBD)
Carbohydrate-based diet (CBD)
Placebo Comparator group
Description:
The CBD group will be asked to avoid whole egg consumption when possible during the 8 week intervention period. They will be counseled to consume a low fat diet with 55:25:20 %energy from CHO:protein:fat. This diet will place an emphasis on consuming lean meats, low fat dairy, whole grains, legumes, fruits and vegetables.
Treatment:
Other: Carbohydrate-based diet (CBD)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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